GALZIN (zinc acetate)
GALZIN is indicated for the treatment of Wilson's Disease.
Details
- Status
- Prescription
- First Approved
- 1997-01-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
GALZIN Approval History
What GALZIN Treats
1 indicationsGALZIN is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Wilson's Disease
GALZIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02868151 | ECR/227/INSP/AP/2014 | Ph 2, Ph 3 | completed | Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers |
| NCT00696410 results posted | HUM0001911 NIHT32-HL007853 | Ph 1 | completed | The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GALZIN FDA Label Details
Indications & Usage
FDA Label (PDF)GALZIN is indicated for the treatment of Wilson's Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.